Instil Bio (UK)
About Instil Bio
Instil Bio is a cell therapy company developing tumor infiltrating lymphocytes (TIL) for the treatment of solid tumor cancers. TIL are a patient’s own T cells harvested from the patient’s tumor, which are then expanded and reinfused into the patient to target and kill cancer cells. Instil is advancing its proprietary TIL manufacturing expertise, technology, and data into clinical trials, including a planned registrational study with its lead candidate and a first-in-human study of its next-generation engineered TIL. The company is led by world-class cell therapy experts and backed by premier global institutional investors.
Instil Bio UK is Instil’s rapidly-growing, Manchester UK-based subsidiary. Our Manchester subsidiary has significant R&D, process development, and clinical manufacturing capabilities, with approximately 35 staff expanding to > 100 staff. Instil Bio UK has been generating cell therapy products for patient use since 2011, including TIL products and external partner genetically engineered T cell products.
IT Manager – Technical Integration
As the IT Manager – Technical Integration you will be expected to provide IT subject matter expertise with the objective to define and assess the risk, impacts and advantages of best-fit integration options. Once agreed by the project team, you will oversee the integration projects through the system life cycle.
This position is a key interface between the critical operating systems and laboratory or manufacturing operations playing a critical role in ensuring that data integrity is maintained through a facility and product life cycle
You will apply your expertise to support and implement new laboratory and manufacturing systems, testing, validation, management, troubleshooting and administration of new and existing systems within a GMP and laboratory environment using local and cloud solutions
Responsibilities (include but not limited to):
• Understand overall IT global corporate strategy and infrastructure including plans
• Define the IT support operational needs.
• Execute rollout based on IT corporate’s guidance
• Educates Instil staff to increase their system knowledge through training users
• Develop work guidelines, procedures and policies for systems and system management
• Work closely with site managers and global teams on new site design and build with respect
Daily, the focus of the role will provide on-site support for GxP systems, Laboratory and Manufacturing users. Specific activities to include (among others):
• Workstation Support in GXP Systems
• Provide assistance with systems validation in coordination with manufacturing and quality teams.
• Vendor assessment, engagement, and management to identify assess, configure, integrate, qualify/validate, and maintain instruments, systems and troubleshoot issues in the GxP environments within which Instil Bio operate
• Audit and review integrated systems for compliance and ongoing improvement to system integration for Technical operations
• Support the development, creation, and revision of written procedures for system administration and operation of GxP systems in both laboratory and manufacturing
• Responsible for ensuring data integrity compliance for 21 CFR Part 11; Eudralex Vol 4 Annex 11; GDPR & HIPA and other regulations and authoritative guidance through
The role is based in Manchester but will require travel to other Instil Bio sites in the UK
Relevant Skills and Experience
To be successful in the role of IT Manager – Technical integration it is likely you will have 5-7 years of experience in providing IT Operations and Infrastructure support in the life sciences industry, specifically the following:
• Biotech or pharmaceutical industry experience
• Broad experience of IT with strong understanding of networks, servers and telecoms.
• Project management experience in leading global or local system setup and integration
• Knowledge and experience of Change management and quality management systems and experience of managing projects within GxP compliant quality systems
• Experience of system validation and equipment qualification and the validation life cycle using risk management principles
• Experience of managing data lifecycle projects through management of in house and 3rd party contractors
• Experience of managing IT integration projects within an FDA/EMA/MHRA GMP regulated quality framework
• Understanding of various protocols, TCP/IP, HTTP(S), SSL, WWW, JMS, FTP, Telnet, DNS, DHCP, VNC, RDP, NAT, SMTP
• Certifications: CompTIA A+, HP Hardware Support, MCSE, or other relevant certifications
• BSc/MSc in Computer Science or Information Systems
• The ability to work in a flexible, team-oriented environment is required.
• Excellent written, verbal communication skills and presentation skills.
• Ability to mentor or provide best practices to other members of the team.
• Must be detail oriented and self-motivating.
• Occasionally moves equipment and/or supplies weighing up to 22 Kg within the facility
Remuneration & Benefits
The salary for the IT Manager – Technical Integration will be competitive within the Biotechnology and wider Scientific sector with actual salary offered reflecting relevant qualifications and experience as well as performance at interview. In any event we anticipate a salary in the £45,000 to £55,000 range together with an attractive bonus and benefits package.
If you would like to join us as IT Manager – Technical Integration at this critical time in our development and you think your skills and experience are a good fit for this role apply with a current CV and we’ll get back to you within a day or two…… click apply for full job details
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